Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214665

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LUMAKRAS (SOTORASIB)
120MG
Marketing Status: Prescription

Active Ingredient: SOTORASIB
Proprietary Name: LUMAKRAS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214665
Product Number: 001
Approval Date: May 28, 2021
Applicant Holder Full Name: AMGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LUMAKRAS (SOTORASIB)
320MG
Marketing Status: Prescription

Active Ingredient: SOTORASIB
Proprietary Name: LUMAKRAS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 320MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214665
Product Number: 002
Approval Date: Jan 20, 2023
Applicant Holder Full Name: AMGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information